| CTRI Number |
CTRI/2016/02/006628 [Registered on: 11/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
08/02/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of first trimester of pregnancy by ayurveda |
|
Scientific Title of Study
|
A controlled clinical study for evaluation of the effect of rasayana drugs and micronized progesterone during first trimester of pregnancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Sharma |
| Designation |
Research Scholar |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT OF SRPT
IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9723085727 |
| Fax |
|
| Email |
prachi16sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR L P DEI |
| Designation |
Professor and HOD |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
PROFESSOR and HOD
DEPT. OF SRPT
IPGT AND RA, G.A.U.
JAMNAGAR
GUJARAT 361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S B DONGA |
| Designation |
ASSO PROFESSOR |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGARV |
| Address |
DEPT. OF SRPT
IPGT AND RA, G.A.U.
JAMNAGAR
GUJARAT 361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
Jamnagar – 361008 |
|
|
Primary Sponsor
|
| Name |
IPGT AND RA GAU JAMNAGAR |
| Address |
INSTITUTE FOR POST GRADUATION TEACHING AND
RESEARCH IN AYURVEDA OPP. CITY B POLICE STATION PN
MARG JAMNAGAR |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| prachi sharma |
Department of srpt |
Dept of SRPT
OPD No.8
IPGTRA
Jamnagar 361008
Jamnagar
GUJARAT |
9723085727
prachi16sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
complaints of first trimester of pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Rasayana drugs in the form of granules 10 gms BD for 2 months. |
| Comparator Agent |
Group B |
Micronized progesteron 200mg BD for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Elderly primigravida
2. Pregnancy after infertility
3. History of threatened abortion.
4. History of habitual abortion.
5. Delayed fetal pole development
6. Choriodecidual hemorrhage
7. History of Blightened ovum, IUFD, Congenital deformity, previous preterm birth,
8. Successful pregnancy after IVF and ET
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy with uterine malformation and congenital defect of uterus.
2. Pregnancy with uterine fibroid and carcinoma.
3. Pregnancy with sexually transmitted disease
4. Severe PIH.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in complaints of first trimester of pregnancy |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| continuation of pregnancy and fetal well being. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/12/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The first trimester of pregnancy lasts from conception until 12 weeks gestation. Women experience a wide range of symptoms as their bodies undergo some amazing changes during the first trimester. Some symptoms during this stage include Nausea and vomiting Fatigue Food aversion Breast growth and tenderness Tiredness Constipation Regurgitation and heartburn Lower abdominal pain Frequency micturation etc.
In Group A rasayana granules 10gm BD for 2 months will be given.
In Group B micronized progesteron 200mg BD will be given for 2 months. |